Sjögren's DiseasePhase 2NCT07836660
A Study of IBI355 in Participants With Moderate-to-Severe Sjögren's Disease
A Phase 2 study testing Part B -Telitacicept and Part A - IBI355 in people with Sjögren's Disease, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IBI355 in participants with moderate-to-severe Sj?gren's disease (SjD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sjögren's Disease
- What is being tested?
- Part B -Telitacicept and Part A - IBI355
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2026to 31 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤75 years.
- Diagnosis of Sjögren's syndrome per 2016 ACR/EULAR classification criteria.
- Duration of Sjögren's syndrome diagnosis ≤7.5 years.
- Serum anti-Ro/SSA (Ro60 and/or Ro52) positive.
- Stimulated whole saliva flow rate ≥0.05 mL/min at screening.
- Baseline ESSDAI score ≥5 in ≥1 of the following domains: systemic, lymphadenopathy, glandular, articular, cutaneous, renal, hematologic, biological.
- Stable background therapy (hydroxychloroquine ≤400 mg/day, methotrexate ≤25 mg/week, or azathioprine ≤150 mg/day) for ≥12 weeks with stable dose ≥8 weeks prior to randomization.
- Stable oral corticosteroid dose (≤10 mg/day prednisone equivalent) for ≥4 weeks prior to randomization.
Who cannot join
- Known hypersensitivity to IBI355 or its excipients.
- Pregnancy or breastfeeding.
- Uncontrolled interstitial lung disease (ILD) associated with Sjögren's syndrome (e.g., FVC <70% predicted, ClinESSDAI pulmonary domain indicating severe activity, or NYHA Class III/IV dyspnea).
- Active or untreated latent tuberculosis (IGRA-positive without ≥1 month prophylactic treatment).
- Chronic hepatitis B (HBsAg+), hepatitis C (HCV RNA+), HIV, or syphilis.
- Prior use of rituximab, other anti-CD20 agents, or other biologics targeting CD40/CD40L, BAFF/APRIL, or CTLA-4 within 6 months prior to randomization.
- Use of JAK/TYK inhibitors within 8 weeks prior to randomization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230001
Xiaomei Li, 13866795533, lixiaomei@fsmy@aliyun.com
Zhen Tan, M.D.
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of IBI355 in Participants With Moderate-to-Severe Sjögren's Disease
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IBI355 in participants with moderate-to-severe Sj?gren's disease (SjD).
Read the detailed description
This study is a randomized, double-blind, placebo-controlled Phase II study in participants with moderate-to-severe Sjögren's disease. Eligible participants will be randomized to receive IBI355 or placebo during the double-blind treatment period.
The study will evaluate the efficacy of IBI355 in reducing systemic disease activity and improving patient-reported symptoms and disease-related functional outcomes. Safety and tolerability will be assessed throughout the study. Pharmacokinetic, immunogenicity, pharmacodynamic, and other relevant clinical assessments will also be performed as specified in the protocol.
The results of this study are intended to characterize the efficacy and safety profile of IBI355 in participants with Sjögren's disease and to support its further clinical development.
- Conditions
- Sjögren's Disease
- Being tested
- Part A - Placebo for IBI355, Part B -Telitacicept, PartB -Placebo for Telitacicept, Part A - IBI355
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part A - Placebo for IBI355Drug
Matching placebo of IBI355， IV ，corresponding dose regimen according to study design
Part B -TelitaciceptDrug
Telitacicept 160 mg SC QW × 24 doses (Weeks 0-24).
PartB -Placebo for TelitaciceptDrug
Matching placebo of Talitacicept ，SC QW × 24 doses.
Part A - IBI355Drug
IBI355,IV,corresponding dose regimen according to study design
| Study group | Role | What they receive |
|---|---|---|
| Part A: IBI355 group | Experimental | IBI355，IV,corresponding dose regimen according to study cohort( Part A) . Receives: Drug: Part A - Placebo for IBI355; Drug: Part A - IBI355 |
| Part B: Telitacicept 160 mg group | Experimental | Participants received telitacicept 160 mg SC QW from Week 0 to Week 24. Follow-up through Week 36 Receives: Drug: Part B -Telitacicept |
| Part A: Placebo group（IBI355-matched） | Experimental | Matching placebo of IBI355， IV ，corresponding dose regimen according to study design Receives: Drug: Part A - Placebo for IBI355; Drug: Part A - IBI355 |
| Part B: Placebo group (Telitacicept-matched) | Experimental | Participants received matching placebo SC QW from Week 0 to Week 24. Follow-up through Week 36. Receives: Drug: PartB -Placebo for Telitacicept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 24
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) is a physician-assessed index used to evaluate systemic disease activity in Sjögren's disease. The total score ranges from 0 to 123, with higher scores indicating greater systemic disease activity. A decrease from baseline indicates improvement.
Measured: Baseline and Week 24
Secondary outcomes (8)
Change from Baseline in ESSDAI Score at Weeks 12 and 48
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) is a physician-assessed index used to evaluate systemic disease activity in Sjögren's disease. The total score ranges from 0 to 123, with higher scores indicating greater systemic disease activity. A decrease from baseline indicates improvement.
Measured: Baseline to Weeks 12 and 48
Change from Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Weeks 12, 24, and 48
The EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is a patient-reported measure assessing dryness, fatigue, and pain. Each domain is rated on a 0-to-10 numerical rating scale, and the total ESSPRI score is calculated as the mean of the three domain scores, ranging from 0 to 10. Higher scores indicate greater symptom severity. A decrease from baseline indicates improvement.
Measured: Baseline to Weeks 12, 24, and 48
Change from Baseline in Stimulated Salivary Flow (sSF) Rate at Weeks 12, 24, and 48
Stimulated salivary flow rate will be measured according to the protocol-specified procedure. An increase from baseline indicates an improvement in stimulated salivary gland function.
Measured: Baseline to Weeks 12, 24, and 48
Change from Baseline in Schirmer Test at Week 48
The Schirmer test is used to assess tear production and is reported as the length of wetting of the test strip over 5 minutes, measured in millimeters (mm/5 min). Higher values indicate greater tear production.
Measured: Baseline to Week 48
Change from Baseline in Sj?gren's Tool for Assessing Response (STAR) Score at Week 48
The Sj?gren's Tool for Assessing Response (STAR) is a composite assessment of treatment response in Sj?gren's disease incorporating systemic disease activity, patient-reported symptoms, and biological and glandular domains. Higher scores indicate a greater treatment response.
Measured: Baseline to Week 48
Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Weeks 12, 24, and 48
The FACIT-Fatigue scale is a 13-item patient-reported measure of fatigue. The total score ranges from 0 to 52, with higher scores indicating less fatigue and better functioning. An increase from baseline indicates improvement.
Measured: Baseline to Weeks 12, 24, and 48
Change from Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score at Weeks 12, 24, and 48
The EQ-5D-5L is a standardized measure of health status assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity. Responses are converted to an EQ-5D-5L index score using the prespecified value set, with higher index scores indicating better health status.
Measured: Baseline to Weeks 12, 24, and 48
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
The number and percentage of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) will be assessed throughout the study.
Measured: From the first dose of study intervention through Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjögren's DiseaseStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836660
- Sponsor's protocol ID
- CIBI355A201
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of IBI355 in Participants With Moderate-to-Severe Sjögren's Disease
- ClinicalTrials.gov ID
- NCT07836660
- Acronym / sponsor ID
- CIBI355A201
- Conditions
- Sjögren's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IBI355 in participants with moderate-to-severe Sj?gren's disease (SjD).
Detailed description
This study is a randomized, double-blind, placebo-controlled Phase II study in participants with moderate-to-severe Sjögren's disease. Eligible participants will be randomized to receive IBI355 or placebo during the double-blind treatment period.
The study will evaluate the efficacy of IBI355 in reducing systemic disease activity and improving patient-reported symptoms and disease-related functional outcomes. Safety and tolerability will be assessed throughout the study. Pharmacokinetic, immunogenicity, pharmacodynamic, and other relevant clinical assessments will also be performed as specified in the protocol.
The results of this study are intended to characterize the efficacy and safety profile of IBI355 in participants with Sjögren's disease and to support its further clinical development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: IBI355 group | Experimental | Drug: Part A - Placebo for IBI355, Drug: Part A - IBI355IBI355，IV,corresponding dose regimen according to study cohort( Part A) . |
| Part B: Telitacicept 160 mg group | Experimental | Drug: Part B -TelitaciceptParticipants received telitacicept 160 mg SC QW from Week 0 to Week 24. Follow-up through Week 36 |
| Part A: Placebo group（IBI355-matched） | Experimental | Drug: Part A - Placebo for IBI355, Drug: Part A - IBI355Matching placebo of IBI355， IV ，corresponding dose regimen according to study design |
| Part B: Placebo group (Telitacicept-matched) | Experimental | Drug: PartB -Placebo for TelitaciceptParticipants received matching placebo SC QW from Week 0 to Week 24. Follow-up through Week 36. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 and ≤75 years.
- Diagnosis of Sjögren's syndrome per 2016 ACR/EULAR classification criteria.
- Duration of Sjögren's syndrome diagnosis ≤7.5 years.
- Serum anti-Ro/SSA (Ro60 and/or Ro52) positive.
- Stimulated whole saliva flow rate ≥0.05 mL/min at screening.
Key exclusion criteria (7 listed)
- Known hypersensitivity to IBI355 or its excipients.
- Pregnancy or breastfeeding.
- Uncontrolled interstitial lung disease (ILD) associated with Sjögren's syndrome (e.g., FVC <70% predicted, ClinESSDAI pulmonary domain indicating severe activity, or NYHA Class III/IV dyspnea).
- Active or untreated latent tuberculosis (IGRA-positive without ≥1 month prophylactic treatment).
- Chronic hepatitis B (HBsAg+), hepatitis C (HCV RNA+), HIV, or syphilis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Part A - Placebo for IBI355Matching placebo of IBI355， IV ，corresponding dose regimen according to study design | Drug | Part A: IBI355 group, Part A: Placebo group（IBI355-matched） |
| Part B -TelitaciceptTelitacicept 160 mg SC QW × 24 doses (Weeks 0-24). | Drug | Part B: Telitacicept 160 mg group |
| PartB -Placebo for TelitaciceptMatching placebo of Talitacicept ，SC QW × 24 doses. | Drug | Part B: Placebo group (Telitacicept-matched) |
| Part A - IBI355IBI355,IV,corresponding dose regimen according to study design | Drug | Part A: IBI355 group, Part A: Placebo group（IBI355-matched） |
Primary outcome
Change from Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 24
Time frame: Baseline and Week 24
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) is a physician-assessed index used to evaluate systemic disease activity in Sjögren's disease. The total score ranges from 0 to 123, with higher scores indicating greater systemic disease activity. A decrease from baseline indicates improvement.
8 secondary outcomes
Change from Baseline in ESSDAI Score at Weeks 12 and 48
Time frame: Baseline to Weeks 12 and 48
Change from Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Weeks 12, 24, and 48
Time frame: Baseline to Weeks 12, 24, and 48
Change from Baseline in Stimulated Salivary Flow (sSF) Rate at Weeks 12, 24, and 48
Time frame: Baseline to Weeks 12, 24, and 48
Change from Baseline in Schirmer Test at Week 48
Time frame: Baseline to Week 48
Change from Baseline in Sj?gren's Tool for Assessing Response (STAR) Score at Week 48
Time frame: Baseline to Week 48
Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Weeks 12, 24, and 48
Time frame: Baseline to Weeks 12, 24, and 48
Change from Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score at Weeks 12, 24, and 48
Time frame: Baseline to Weeks 12, 24, and 48
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From the first dose of study intervention through Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Part B -Telitacicept and Part A - IBI355 in people with Sjögren's Disease, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiaoyan li (18756032014, xiaoyan.li@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 24 (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.